MAUDE Adverse Event Report: Medline Industries, LP MEDLINE CO-LABEL; SCANNER,BLADDER,BIOCON 750,W/PRINTER

Catalog Number	MDSB10750
Medical Device Problem Code	No Visual Prompts/Feedback (4021)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "scanner is not showing pink cross hairs when trying to scan.".
Additional Manufacturer Narrative
The customer stated that the scanner is not showing pink cross hairs when trying to scan; no error code was received.Medline reviewed the reported product problem/issue of pink cross hairs not appearing and complaint information received, and the complaint was processed as a servicing request because it is not a pmdr or out of box failure related issue.The reported problem was unconfirmed, and the cause code was unconfirmed - servicing request; no root cause was identified.The reported complaint event was reviewed and did not involve a death or serious injury, and there has been no change to the reportability decision associated with this complaint.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE CO-LABEL
• Common Device Name: SCANNER,BLADDER,BIOCON 750,W/PRINTER
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: vamshi pinnamshetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50867891
• Report Number: 1417592-2026-48642
• Device Sequence Number: 13427234
• Product Code: IYO
• UDI-Device Identifier: 40884389154893
• UDI-Public: 40884389154893
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: MDSB10750
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown